Method of making an injection or sampling site

ABSTRACT

A method of making an injection and sampling site adapted to receive a blunt cannula. The method comprises providing an elastomeric septum, and a housing adapted to receive that septum; making a slit in the elastomeric septum; inserting the elastomeric septum into the passageway of the housing; and swaging an outer annular ledge on the housing inwardly over the septum until a septum-engaging portion of the swaging tool applies a predetermined amount of force to the septum. Before the swaging step, a pin is inserted into the passageway of the housing against the inside end of the septum to inhibit deformation of the septum during swaging.

This application is a continuation-in-part of U.S. patent applicationSer. No. 07/921,908, filed Jul. 29, 1992, now U.S. Pat. No. 5,300,034.

BACKGROUND OF THE INVENTION

This invention relates generally to infusion therapy and IV injection orsampling sites, and more particularly to apparatus for and method ofmaking an injection or sampling site, such as an IV injection site,adapted for use with a blunt cannula.

In an effort to reduce the risk of transmitting infectious diseases,such as hepatitis and AIDS, via accidental needle sticks, variousdesigns of IV injection sites have been developed that are adapted toreceive a blunt cannula and/or shielded cannula. See, e.g., SpecialReport and Product Review, Needlestick-Prevention Devices, HealthDevices, pages 154-180 (ECRI, Plymouth Meeting, Penn. 1991). Oneapproach has been to employ a slit septum Y-site in which a slitelastomeric septum is compressed in the Y-site housing. A blunt cannulacan be introduced through the slit of the septum, and assuming thedesign works as intended, the septum will seal against the cannulashaft. When the cannula is removed, the septum seals itself.

Injection sites of this type are either available from or publicized byBaxter International, Inc., Deerfield, Ill., under the trade designation"Baxter's Needle-Less Injection Sites"; Abbott Laboratories, Inc.,Abbott Park, Ill., under the trade designation "LifeShield InfectionControl System"; and Kendall McGaw Laboratories, Inc., Irvine, Calif.,under the trade designation "SafeLine No-Needle I.V. System". A bluntcannula has been available from Becton, Dickinson and Company, Paramus,N.J., under the trade designation "Interlink System".

One problem with these systems is that they are sometimes incompatible.Some slit septum systems have permitted leakage either when a cannula isinserted or when no cannula has been inserted. In at least one slitseptum site, it is possible to upset the septum in its housing by usingan unspecified cannula or attempting to insert the cannula through thematerial of the septum somewhere other than through the slit.

Another problem with slit septum systems is inconsistent resistance tobeing pierced with a blunt cannula. Injection sites of the same systemwill require the medical practitioner to exert widely varying amount offorce before the blunt cannula will pierce the septum.

SUMMARY OF THE INVENTION

This invention provides an apparatus for and method of making aninjection or sampling site, such as an IV injection Y-site on an IVtubing set, adapted to receive a blunt cannula. The apparatus and methodprovide improved process consistency compared to prior methods, andlower and more consistent penetration forces when a blunt cannula isinserted in the IV injection site made according to the method. Theapparatus and method also provide a relatively economical means formaking injection or sampling sites.

Generally, the method according to the invention is performed on ahousing having an outside end and a passageway extending inwardly fromthe outside end, the passageway opening through the outside end anddefining a longitudinal direction, and an elastomeric septum having anoutside end corresponding to the outside end of the housing and aninside end opposite its outside end. In one aspect of the method, theelastomeric septum is inserted into the passageway of the housing; a pinis inserted into the passageway of the housing to engage the inside endof the septum to reduce or prevent expansion of the septum inwardlythrough the passageway when the outer end of the housing is swaged; andthe outside end of the housing is swaged inwardly over the septum with aswaging tool during or after insertion of the pin.

Preferably, the swaging process is stopped when the swaging tool appliesa predetermined amount of force to the septum. The swaging toolpreferably has a septum-engaging portion and a housing-swaging portion,and the septum is engaged with the septum-engaging portion of theswaging tool before stopping the swaging process.

Most preferably, the septum has a bore extending part-way through theseptum from the inside end of the septum, and the pin is also insertedinto the bore of the septum.

Accordingly, in its first aspect, the invention facilitates fabricatingan injection or sampling site in which the housing is swaged withoutlongitudinal compression of the septum. By preventing deformation of theseptum during the swaging process with the swaging tool, pin and thewalls of the housing, longitudinal compression is also prevented. Thisis because the elastomeric material of the septum is incompressible. Theresulting injection or sampling site is believed to provide moreconsistent penetration force required to pierce the septum with a bluntcannula.

In another aspect of the method of the invention, the a slit is cut intoan elastomeric septum. The method may be performed with an apparatus forslitting the septum, which apparatus comprises a block having aseptum-receiving bore, a back support for supporting one end of theseptum, and a knife. The septum is inserted into the septum-receivingbore against the back support, with the septum-receiving bore laterallyor radially capturing the septum to prevent radial deformation of theseptum. A slit is then cut into the septum with a knife, with the knifebeing aligned with the septum-receiving bore and the septum captured inthe bore such that the slit is aligned with respect to the septum. Aftercutting the slit into the septum, the septum is removed from theseptum-receiving bore. During or after removal of the septum from theseptum-receiving bore, the septum is inserted into a housing of aninjection or sampling site.

Accordingly, in one aspect of the method of the invention, the septum isheld in a septum-receiving bore and prevented from deforming laterallyor radially while a slit is cut into the septum with a knife. As aresult, the knife is able to cut a precisely aligned or centered slitthrough the septum. This is accomplished on a consistent basis.

In one preferred version, the method comprises first slitting the septumaccording to the slitting method described above, loading the slitseptum into a housing, and swaging the outside end of the housinginwardly over the septum according to the swaging method describedabove.

The apparatus of the invention, in one aspect, generally comprises pinmeans, swaging means and means for stopping the swaging means. The pinmeans is adapted to reduce or prevent expansion of the septum inwardlythrough the passageway when the outer end of the housing is swaged. Thepin means is inserted into the passageway of a housing into engagementwith the inside end of a septum inserted into the passageway. Theswaging means swages the outside end of the housing inwardly over theseptum. The means for stopping the swaging means stops the swaging meansfrom further swaging of the housing when the swaging means applies apredetermined amount of force to the septum.

Preferably, the swaging means comprises a swaging tool having aseptum-engaging portion and a housing-swaging portion. Theseptum-engaging portion and housing-swaging portion are configured, andthe means for stopping the swaging means is adapted, to stop the swagingprocess before the outside end of the housing applies longitudinalcompression to the septum.

In another aspect, the apparatus of the invention generally comprises ablock, a back support, a knife, and pushing means. The block has aseptum-receiving bore for receiving a septum before it is inserted intoa housing, with the septum-receiving bore laterally or radiallyconstraining the septum to prevent lateral or radial deformation of theseptum. The back support supports one end of the septum received in theseptum-receiving bore of the block. The knife is movable relative to theseptum-receiving bore of the block to cut a slit into a septum receivedin the septum-receiving bore. The pushing means removes the septum fromthe septum-receiving bore and inserts the septum into the passageway ofa housing.

Preferably, the septum-receiving bore has a diameter substantially equalto the diameter of a housing into which a septum will be inserted.

Most preferably, the slitting apparatus and the swaging apparatus arecombined into one apparatus that slits the septum and swages thehousing. The apparatus conveniently comprises two turntables, the firstof which holds septums for slitting, and the second of which holdshousings into which the slit septums are transferred before the housingsare swaged.

For example, the first turntable (also constituting the block) has aplurality of septum-receiving bores, and is mounted for rotationrelative to the back support to move the septum-receiving bores relativeto the back support between slitting and unloading stations. At theunloading station, the back support has a passageway sized to allow aseptum received in the septum-receiving bore to be pushed through thepassageway by the pushing means. The septum-receiving bore of the firstturntable at the slitting station is not adjacent the passageway of theback support.

The second turntable has a plurality of housing-receiving openings forreceiving the housing of the injection or sampling site, and isrotatable to move the housing-receiving openings between aseptum-loading station and a swaging station. At the septum-loadingstation, a housing-receiving opening is aligned with the passageway ofthe back support to enable a septum to be loaded into a housing receivedin that housing-receiving opening. At the swaging station, thehousing-receiving opening is aligned with the swaging means to enablethe swaging means to swage the outside end of a housing received in thathousing-receiving opening.

Most preferably, a means is provided for controlling the knife, pushingmeans and swaging means to substantially simultaneously (a) cut a septumreceived in the septum-receiving bore at the slitting station with theknife, (b) push a septum received in the septum-receiving bore at theunloading station of the first turntable with the pushing means into ahousing received in a housing-receiving opening at the septum-loadingstation of the second turntable, and (c) swage the end of a housinginwardly over the septum at the swaging station with the swaging means.For example, the means for controlling the knife, pushing means andswaging means may comprise pneumatic means for moving the knife, pushingmeans and swaging means through their operative range of motion.

Other features will be pointed out hereinafter.

BRIEF DESCRIPTION OF THE DRAWING

The invention will be further described with reference to the drawingwherein corresponding reference characters indicate corresponding partsthroughout the several views of the drawing, and wherein:

FIG. 1 is an enlarged cross-sectional view of the IV injection site,showing a novel septum and housing design;

FIG. 2 is a top plan view of the IV injection site of FIG. 1;

FIG. 3 is a cross-sectional view of the septum of FIG. 1, illustratingits configuration before it is assembled in the housing of the IVinjection site;

FIG. 4 is an enlarged cross-sectional view of the IV injection site ofFIGS. 1 and 2 and a blunt cannula, showing the IV injection site beforethe cannula has been introduced therein;

FIG. 5 is an enlarged cross-sectional view of the IV injection site andcannula of FIG. 4, showing the cannula partly inserted into theinjection site;

FIG. 6 is an enlarged cross-sectional view of the IV injection site andcannula of FIGS. 4 and 5, showing the cannula substantially completelyinserted into the injection site;

FIG. 7 is an enlarged cross-sectional view of an alternative embodimentof the IV injection site;

FIG. 8 is a diagrammatic view of an apparatus of the invention forfabricating injection or sampling sites;

FIG. 9 is a top plan view illustrating first and second turntables ofthe apparatus rotatable relative to a plurality of stations, including aslitting station and a swaging station, to perform the various processesthat result in an assembled injection or sampling site;

FIG. 10 is a cross-sectional view substantially along arcs of theturntables shown in FIG. 9, illustrating in a linear fashion thearrangement of selected stations relative to the first and secondturntables of the apparatus;

FIG. 11 is a cross-sectional view similar to FIG. 10, illustrating thesubstantially simultaneous cutting of a slit in the septum at theslitting site of the first turntable, transferring of the septum at theunloading station of the first turntable to the septum-loading stationof the second turntable, and swaging of the housing at the swagingstation of the second turntable;

FIG. 12 is an enlarged perspective view of a knife used at the slittingstation of FIGS. 8-11;

FIG. 13 is an enlarged view of a swaging tool used at the swagingstation of FIGS. 8-11; and

FIG. 14 is a flow chart illustrating the method of the invention offabricating an injection or sampling site with the apparatus of FIGS.8-13.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 1. IV Injection Site

Now referring to the drawing, a preferred IV injection site made withthe apparatus and method of the invention is designated in its entiretyby the reference numeral 10. The IV injection site 10 may be of thegeneral type known as a Y-site, which provides a sealed port forinjecting fluids into an IV tubing set (not shown). It is contemplatedthat the injection site 10 could be used in such IV administrationtubing sets, drug vials, or other fluid systems involving medical fluidsor a medical setting. The injection site 10 is particularly designed tobe used with a blunt plastic or metal cannula 12 (FIGS. 4-6) that has arelatively smooth end 14 to reduce the risk to medical personnel ofaccidental needle sticks.

The injection site 10 generally comprises a housing 16 having an outsideend 18 and a passageway 20 extending inwardly from the outside end 18.The passageway 20 defines a longitudinal direction. An elastomericseptum 22 is closely received in the passageway 20 of the housing 16.The septum 22 has inside and outside ends 24 and 26 relative to theoutside end 18 of the housing 16. A bore 28 extends into the septum 22from the inside end 24 of the septum 22 generally in the longitudinaldirection but not through the septum 22, and a slit 30 extends generallyin the longitudinal direction into the septum 22 from the outside end 26of the septum 22 to the bore 28.

The arrangement is such that, when a cannula 12 is introduced throughthe slit 30 of the septum 22, the elastomeric material of the septum 22expands into the bore 28 of the septum 22 to sealingly engage thecannula 12 along the bore 28 of the septum 22.

The housing 16 includes opposed inner and outer annular ledges 32 and 34defining a septum-receiving portion 21 of the passageway 20. The innerledge 32 engages the inside end 24 of the septum 22 adjacent theperiphery thereof, and the outer ledge 34 engages the outside end 26 ofthe septum 22 adjacent the periphery thereof. The septum-receivingportion 21 of the passageway 20 is generally cylindrical.

Preferably, the septum 22 is formed, before being inserted in thehousing 16 during assembly of the IV injection site 10, in a combinedfrustoconical/cylindrical configuration as illustrated in FIG. 3. Thepre-assembly septum 22 includes a generally frustoconical portion 36adjacent the inside end 24 of the septum 22 and tapering downwardly inthe direction toward the inside end 24, and a generally constantdiameter cylindrical portion 38 extending from the frustoconical portion36 to the outside end 26 of the septum 22. The septum 22 is compressedradially by the housing 16 so as to have a generally cylindricalconfiguration after the septum 22 has been inserted in the housing 16during assembly of the IV injection site 10.

Most preferably, the bore 28 of the septum 22 extends between 25-50%through the septum 22 and the slit 30 of the septum 22 extends between50-75% through the septum 22, and the frustoconical portion 36 of theseptum 22 extends a greater distance from the inside end 24 of theseptum 22 than the bore 28 extends from the inside end 24 of the septum22. As an illustrative example of the pre-assembly dimensions of theseptum 22, the bore 28 may have a depth of approximately 0.105 inches(2.7 mm); the slit 30 may have a depth (longitudinally along the septum22) of approximately 0.129 inches (3.3 mm); the frustoconical portion 36may have a length of approximately 0.164 inches (4 mm); and thecylindrical portion 38 may have a length of approximately 0.070 inches(1.8 mm). These dimensions change somewhat when the septum 22 isinserted into the housing 16 during assembly of the injection site 10.

The septum-receiving portion 21 of the passageway 20, which is definedas that portion 21 between the inner and outer ledges 32 and 34, isdefined by a generally cylindrical wall (also 21) having a generallyconstant diameter.

The diameter of the septum-receiving portion 21 is most preferablygreater than the smallest pre-assembly diameter of the frustoconicalportion 36 of the septum 22 but smaller than the largest pre-assemblydiameter of the frustoconical portion 36 or cylindrical portion 38 ofthe septum 22. For example, the diameter of the septum-receiving portion21 of the housing 16 may be approximately 0.290 inches (7.4 mm); thepre-assembly diameter of the cylindrical portion 38, which equals thelargest diameter of the frustoconical portion 36, may be approximately0.322 inches (8.2 mm); and the smallest pre-assembly diameter of thefrustoconical portion 36 may be approximately 0.280 inches (7.1 mm).

The arrangement is such that the greatest compression is appliedadjacent the outside end 26 of the septum 22. In the illustrativeexample provided above, the compression applied by the wall of thehousing 16 against the cylindrical portion 38 reduces the diameter ofthe cylindrical portion approximately ten percent from its uncompressedconfiguration. FIG. 3 illustrates in phantom the configuration of theseptum 22 after assembly in the housing 16.

The outer ledge 34 of the housing 16 defines a generally circularopening 40 where the outside end 26 of the septum 22 is exposed throughthe outside end 18 of the housing 16. The outside end 24 of the septum22 includes an annular ridge 42 extending through the generally circularopening 40, and an annular channel 44 concentric with the annular ridge42 and having a diameter greater than the diameter of the annular ridge42. The outer ledge 34 has an annular inner edge 46 received in theannular channel 44 of the septum 22.

For example, the annular ridge 42 of the septum 22 may have an outerdiameter of approximately 0.16 inches (4.1 mm) concentric with thecentral axis of the septum 22; an inner diameter of approximately 0.12inches (3.0 mm); and a generally hemispherical cross-sectionalconfiguration, with a cross-sectional radius of approximately 0.01inches (0.25 mm).

The slit 30 is preferably formed in the molded septum 22 by cutting witha small blade (224 in FIG. 12), which may be inserted longitudinallythrough the outside surface 26 of the septum 22. As an illustrativeexample, if the diameter of the cannulae 12 most likely to be used inthe septum 22 is approximately 0.05-0.10 inches (1.3-2.5 mm), the lengthof the slit 30 (laterally along the septum 22) may be approximately0.03-0.08 inches (0.76-2.0 mm).

Most preferably, the slit-cutting blade (224 in FIG. 12) has a width ofapproximately 0.050 inches (1.27 mm) to cut a slit 30 having a length ofapproximately 0.050 inches (1.27 mm). This is believed to be optimum foruse with the cannulae available under the trade designation "Needle-LessInjection Cannula", from Baxter International, Inc., Deerfield, Ill., aswell as workable with the cannulae available from Abbott Laboratories,Inc., Abbott Park, Ill. under the trade designation "LifeShieldInfection Control System". The outer diameter of Baxter's "Needle-LessInjection Cannula" is approximately 0.100 inches (2.5 mm), and the outerdiameter of Abbott's "LifeShield" cannula is approximately 0.05 inches(1.27 mm).

Most preferably, the bore 28 of the septum 22 is larger than thediameter of the cannula 12 before the cannula 12 is introduced into theslit 30 of the septum 22. When the cannula 12 is introduced through theslit 30 (FIG. 5), the bore 28 of the septum is decreased in crosssection by movement of the material of the septum 22 displaced by thecannula 12 such that the septum 22 sealingly engages the cannula 12along the bore 28 of the septum 22.

For example, the bore 28 of the pre-assembly septum 22 preferably isgenerally cylindrical and has a diameter of approximately 0.120 inches(3.05 mm), which is believed to be optimum for a cannula 12 having aoutside diameter of approximately 0.100 inches (2.5 mm). The diameter ofthe bore 28 of the septum 22 is smaller after assembly of the injectionsite 10 than before due to radial compression of the septum 22 in theseptum-receiving portion 21 of the housing 16.

The septum 22 is preferably integrally molded of a suitable elastomericmaterial, such as polyisoprene (natural or synthetic). The mostpreferred polyisoprene materials are synthetic, and have a durometer ofapproximately 35 on the Shore A scale and a compression set ofapproximately 16.4%. Suitable polyisoprene materials include "5218 or5251 Gum Rubber" available from Abbott Laboratories, Inc. Abbott Part,Ill.; "1028 GUM Rubber" and Catalog Nos. "2-2-3 7389-35" and "2-6-2X7389-35" available from The West Company, Phoenixville, Penn.; andCatalog No. "L 3819" available from Neff Perkins Co., Painesville, Ohio.A silicone formulation available under Catalog No. "L 4795" from NeffPerkins Co., may also be suitable.

As used herein, "integrally molded" means molded in one continuouspiece, as opposed to a number of pieces mechanically positionedtogether. The arrangement should be such that material displaced fromthe slit 30 is primarily directed to shrinking the diameter of the bore28.

The housing 16 is preferably injection molded of a suitable syntheticresin material, such as acrylonitrile-butadiene-styrene (ABS), or one ofthe copolyester or copolyester/polycarbonate blends available under thetrade designations "DN003" or "DA003" from Eastman Chemical Company,Kingsport, Tenn. The material of the housing 16 is relativelyun-yielding in normal use compared to the elastomeric material of theseptum 22 so that the walls of the septum-receiving portion 21 of thepassageway 20 do not expand significantly when the slit 30 is expandedby the cannula 12. The result is that the walls of the septum-receivingportion 21 of the passageway 20, as well as the inner and outer ledges32 and 34, help direct the displaced material of the septum 22 to shrinkthe bore 28.

Most preferably, the outer ledge 34 is swaged to bend it inwardly overthe outside end 26 of the septum 22 to hold the septum 22 in the housing16 as discussed below. It is also contemplated that the outer ledge 34could be spin swaged, ultrasonically deformed or deformed by a hotair/cold anvil process to bend it against the outside end 26 of theseptum 22. Alternatively, the housing 16 could be molded in more thanone piece that are assembled together to hold the septum 22 in place.

The IV injection site 10 may be in the form of a Y-site (also 10) asillustrated in the drawing, with an upstream arm 48, a downstream arm 50and the septum-receiving portion 21. The inner walls of the upstream anddownstream arms 48 and 50 define a lumen 52 extending in fluidcommunication with the passageway 20 along the inside end 24 of theseptum 22. The upstream and downstream arms 48 and 50 are adapted to bemounted on the ends of conventional IV tubing (not shown).

The downstream arm 50 extends co-axially from the septum-receivingportion 21 so that insertion of the end 14 of the cannula 12 piercingthe septum 22 is not stopped by the lumen-defining wall of thedownstream arm 50. The downstream arm 50 preferably extends downwardly adistance from the outside end 26 of the septum 22 greater than theanticipated length of the cannula 12 to isolate the downstream sectionof IV tubing (not shown) from possible contact with the end 14 of thecannula 12.

The IV injection site 10 may be positioned along tubing sets of thetypes disclosed in co-assigned U.S. Pat. Nos. 4,236,880; 4,277,226;4,322,201; 4,637,817; 4,673,390; 4,705,506; 4,714,463; and 5,017,192,which show infusion therapy systems and are incorporated herein byreference. In such a system, one injection site 10 could be positionedalong the tubing set (not shown) upstream relative to an infusion pump(not shown) and another injection site 10 could be positioned along thetubing set downstream of the infusion pump.

The upstream IV injection site 10 provides a convenient mechanism toconnect a second source of fluid into the multiple solution IV therapysystems disclosed in U.S. Pat. Nos. 4,637,817; 4,673,390; 4,705,506; and4,714,463. The injection site 10 can also be used in conventionalgravity flow IV tubing sets (not shown) of the type designed to be usedwithout an infusion pump, as well as with drug vials, or other medicalinjection sites. As used herein "IV injection site" refers among otherthings to IV Y-sites; injection or withdrawal sites in drug vialsholding drugs to be administered intravenously; and sampling sitesthrough which fluid is withdrawn from a tubing set, for example, asampling site in an extracorporeal cardiovascular support circuit.

FIG. 7 illustrates an alternative embodiment of the IV injection site,here designated 10A, similar to injection site 10 but in which theinside end 24A of the septum 22A includes an annular skirt 100 extendinglongitudinally inwardly from the septum 22A. (Reference numerals endingwith an "A" in FIG. 7 designate parts designated in the other figures bythe same reference numerals without the "A" ending.) The inner ledge 32Aof the housing 16A includes an annular skirt-receiving channel 102 forreceiving the skirt 100 of the septum 22A.

The skirt 100 and skirt-receiving channel 102 help stabilize the septum22A in the housing 16A, and the relative dimensions of the skirt 100 andchannel 102 facilitate fine tuning of the change in diameter of the bore28A when a cannula 12 is inserted into the site 10A. As illustrated inFIG. 7, the channel 102 is deeper than the skirt 10 is long, providingspace for expansion of the elastomeric material of the septum 22A when acannula 12 expands the slit 30A, with the result that the diameter ofthe bore 28A would not shrink as much as the bore 28 of the injectionsite 10. The skirt-receiving channel 102 could alternatively have alength substantially equal to the length of the skirt 100 so that moreof the material displaced by the cannula 12 piercing the slit 30A isdirected to shrinking the diameter of the bore 28A.

The septum 22A of the alternative injection site 10A may also include anannular stepped shoulder 104 along the periphery of its outside end 26Aso that the outside end 18A of the housing 16A is approximately flushwith the outside end 26A of the septum 22A. The outer ledge 34A may beultrasonically crimped to retain the septum 22A in position. It is alsocontemplated that the septum 22A would be tapered (possibly similarly tothe septum 22) so that the greatest radial compression is providedadjacent the outside surface 26A of the septum 22A.

Although not preferred or shown, the septum-receiving portion mayalternatively have a tapered configuration, with the smallest diameterbeing provided adjacent the outside end of the housing, to providegreater compression along the outside surface than elsewhere along theseptum, although this arrangement results in more difficult assembly ofthe injection site. Assembling a multi-part housing (not shown) would beone way of manufacturing a housing having such a taperedseptum-receiving portion. Such a multi-part housing may include one ormore parts of a different color to indicate that the injection site isintended for use with a blunt cannula.

2. Operation of Injection Site

The operation of the IV injection site 10 will now be described. First,the cannula 12 is introduced into the slit 30 of the septum 22. As thisis done, the cannula 12 expands the elastomeric material of the septum22 to enlarge the slit 30 to receive the cannula 12. Since the materialof the septum 22 is practically incompressible, the elastomeric materialof the septum 22 displaced by the cannula 12 is directed by the housing16 toward the bore 28 of the septum 22 to decrease the diameter of thebore 28. The diameter of the bore 28 of the septum 22 is decreased toless than or equal to the diameter of the cannula 12.

The cannula 12 is then introduced into the bore 28 of the septum 22 bycontinuing to insert the cannula 12 through the slit 30. This results inthe septum 22 sealingly engaging the cannula 12 along the bore 28 of theseptum 22. Because the diameter of the bore 28 of the septum 22 had beendecreased to less than or equal to the diameter of the cannula 12, theelastomeric material of the septum 22 along its bore 28 presses againstthe cannula 12 when the cannula 12 is introduced into the bore 28 of theseptum 22.

When the cannula 12 is removed from the injection site 10, the septum 22returns to its normal configuration, with the slit 30 sealing againstleakage.

3. Apparatus for Making the Injection Site

The apparatus 200 for making the injection or sampling site 10 will bedescribed with reference to injection site 10 shown in FIGS. 1-6 (exceptthat the outside end 26 of the septum 22 is flat), although theapparatus 200 may be adapted for use with other injection sites,including the injection site 10A shown in FIG. 7 and injections sites(not shown) in which the septum is not provided with a bore. FIGS. 8-13illustrate one embodiment of the apparatus 200, and FIG. 14 is a flowchart illustrating the method of use of the apparatus 200.

As illustrated in FIGS. 8-11, apparatus 200 comprises two turntables 202and 204. The first turntable 202 comprises a block (also 202) having aplurality of septum-receiving bores 206 for receiving the septums 22.The first turntable 202 is rotatable relative to a back support 208between different rotational positions. At each one of these rotationalpositions, as illustrated in FIGS. 10 and 11, one septum-receiving bore206 is at a loading station 210, a second septum-receiving bore 206 isat a slitting station 212 and a third septum-receiving bore 206 is at anunloading station 214.

The second turntable 204 has a plurality of housing-receiving openings216 for receiving the housings 16. The second turntable 204 is rotatableto move the housing-receiving openings between a housing-loading station218, a septum-loading station 220, a swaging station 222, and anunloading station 223. The unloading station 214 of the first turntable202 and the septum-loading station 218 of the second turntable 204 arealigned to permit loading a septum 22 from the first turntable 202 intoa housing 16 held in the second turntable 204.

The loading station 210 of the first turntable 202 is where the septums22 are loaded into the septum-receiving bores 206. It is contemplatedthat such loading may be accomplished by any suitable conventionalmeans, including manually or automatically inserting the septums 22 intothe septum-receiving bores 206. FIGS. 8, 10 and 11 show a loading means211 for loading the septum 22 into a septum-receiving bore 206, whichcomprises a pusher 211 that is operable to push the septum 22 into theseptum-receiving bore. The loaded septums 22 are moved to the slittingstation 212 by rotation of the first turntable 202.

The first turntable 202 is part of the slit cutting means of theapparatus 200, which includes at the slitting station 212 a knife 224that is movable relative to the septum-receiving bore 206 positioned atthe slitting station 212 to cut a slit 30 into the septum 22 received inthat septum-receiving bore 206. A preferred configuration of the knife224 has a sharp, chisel-shaped edge as illustrated in FIG. 12. The backsupport 208 preferably has a knife-receiving opening 226 in alignmentwith the knife 224 for receiving the knife 224 when the slit 30 is cutinto the septum 22.

At the slitting station 212, the back support 208 supports the septum 22to hold the septum 22 in the septum-receiving bore 206 while the knife224 is cutting the slit 28 into the septum 22. When at the slittingstation 212, a septum-receiving bore 206 of the first turntable 202 isnot adjacent the passageway 228 through the back support 208.

The septum-receiving bores 206 laterally or radially capture andconstrain the septums 22 to prevent lateral or radial movement of theseptums 22 while the knife 224 is cutting the slit 30. This is believedto result in consistently aligned or centered slits 30 in the septums22.

The septum-receiving bores 206 are preferably generally cylindricalhaving a generally constant diameter substantially equal to the diameterof the septum-receiving portion 21 of the passageway 20 of the housing16 into which the septum 22 will be inserted. This diameter providessubstantially equal radial compression to the septum 22 as it will havewhen inserted into the housing 16, which is helpful in maintainingproper alignment of the slit 30 relative to the housing 16. As analternative, the septum-receiving bores (not shown) may have afrustoconical configuration generally corresponding to the frustoconicalconfiguration of the preferred septum 22, or the septum-receiving bores(also not shown) may have other configurations generally correspondingto the septum-receiving portion of the particular housing being used.

The first turntable 202 is designed to rotate the septum-receiving bore206 that is at the slitting station 212 to the unloading station 214after the septum 22 in that septum-receiving bore 206 has been slitted.At the unloading station 214, the back support 208 is provided with apassageway 228 to allow the septum 22 to be pushed through thepassageway 228 with a suitable pushing means, such as a push rod or tool230, to remove the septum 22 from the septum-receiving bore 206 andinsert the septum 22 into the passageway 20 of a housing 16 held at theseptum-loading station 220 of the second turntable 204. Preferably, thepassageway 228 at the unloading station 214 is at least equal in crosssectional size to a septum-receiving bore 206, but the passageway 228may be sized substantially larger than the size of the septum-receivingbore 206.

The second turntable 204 is a part of the apparatus 200 designed to holdhousings 16 (a) to load a septum 22 into each housing 16, and (b) toswage the outside end 18 of the housing 16 inwardly over the septum 22loaded therein. The slitting part (e.g., stations 210, 212 and 214) ofthe apparatus 200 could be used separately, or in a different process,such as one where a cap (not shown) is mounted on the housing to holdthe septum in position, or with a different type of second turntablethan will be described herein. The swaging part (e.g., stations 218, 220and 222) of the apparatus 200 could be used separately from the slittingpart, or could be used with a different slitting process, for example, aprocess in which the slit is cut into a septum that has already beenloaded into the housing, before or after swaging the housing.

The housing-loading station 218 of the second turntable 204 is where thehousings 16 are loaded into the housing-receiving openings 216. It iscontemplated that such loading may be accomplished by any suitablemeans, including manually or automatically inserting the housings 16into the housing-receiving openings 216. For example, a conventionalhopper or shaker table (not shown) may be used to provide housings 16 tothe housing-receiving openings 216. The housing-receiving openings 216may have a configuration permitting only up-right placement of thehousings 16, with their outside ends 18 facing upwardly.

The loaded housings 16 are moved from the housing-loading station 218 tothe septum-loading station 220 by rotation of the second turntable 204.At the septum-loading station 220, a housing-receiving opening 216 isaligned with the passageway 228 of the back support 208, and with theseptum-receiving bore 206 of the first turntable 202 that is at theunloading station 214, to enable the septum 22 held in thatseptum-receiving bore 206 to be loaded in the housing 16 held at theseptum-loading station 220. As discussed above with respect to the firstturntable 202, the septums 22 are pushed from the unloading station 214of the first turntable 202 into the housing 16 held at theseptum-loading station 220 of the second turntable 204 by the pushingtool 230. The septum 22 and housing 16 are then moved from theseptum-loading station 220 to the swaging station 222 by rotation of thesecond turntable 204.

The swaging station 222 includes a swaging tool 232 for swaging theoutside end 18 of the housing 16 inwardly over the septum 22 (see, e.g.,FIG. 11), and a pin 234 that is inserted into the lower end of thepassageway 20 of the housing 16 against the lower part of the septum 22to prevent movement of the septum 22 into the passageway 20 of thehousing 16 during the swaging operation. When used with septums 22having a bore 28 therein, the pin 234 is configured to be closelyreceived in the bore 28 of the septum 22 to prevent movement of thematerial of the septum 22 into the bore 28.

At the swaging station 222, a housing-receiving opening 216 is alignedwith the swaging tool 232 to enable the swaging tool 232 to swage theoutside end 18 of a housing 16 received in that housing-receivingopening 216. The pin 234 is in alignment with that housing-receivingopening 216, the passageway 20 of the housing held in thathousing-receiving opening 216, and the swaging tool 232.

The preferred arrangement of the swaging tool 232 and pin 234 is such asto substantially completely constrain the septum 22 in position in theseptum-receiving portion 21 of the housing 16. As best illustrated inFIG. 13, the end 236 of the swaging tool 232 is preferably configured toinclude a septum-engaging portion 238 that engages the outside end 26 ofthe septum 24 to prevent additional downward movement of the swagingtool 232 when the outside end 18 of the housing 16 just touches theoutside end 26 of the septum 22.

Because (a) the elastomeric material of the septum 22 is volumetricallyincompressible; and (b) movement and deformation of the septum 22 areprevented by the pin 234, the passageway-defining walls of the housing16 and septum-engaging portion 238 of the swaging tool 232; the outerledge 34 formed by the swaged outside end 18 of the housing 16 isprevented from longitudinally compressing the septum 22. This isbelieved to improve the consistency of the septums 22 assembled ininjection sites 10 with this apparatus 200 compared with conventionalswaging apparatus so that the insertion force required to insert a bluntcannula 12 through the slit 30 of the septum 22 is consistent,notwithstanding variations in the septums 22 and housings 16 fed intothe apparatus 200.

In conventional swaging processes, normal tolerances for septums, whichare molded of elastomeric materials (e.g., latex rubber), can providesignificant performance differences when held in swaged housings due toinconsistent vertical or longitudinal compression of the septums. Forexample, if three varying thickness septums are placed in a housing, andthe outside end of the housing is swaged over the septum by conventionalswaging apparatus (not shown): (a) the relatively thick septum may beoverly compressed increasing the required penetration force that must beexerted to insert a cannula through the septum, (b) in extreme casesthere may actually be a gap between the relatively thin septum and theswaged end of the housing, and (c) only the septum having the normalthickness will provide the specified penetration force required topenetrate the septum with a blunt cannula. "Conventional swagingapparatus" refers to apparatus that does not include a pin 234 and doesnot include a septum-engaging portion 238 on the swaging tool 232.

On the other hand, with the apparatus 200 of this invention, if thethickness of one septum 22 is slightly greater than another septum 22,the swaging station 222 is designed to bring the outer ledge 34 intocontact with either septum 22 without a gap (or at most with a minimalgap) in the case of the thinner septum 22 and without vertical orlongitudinal compression of the relatively thicker septum 22. Thepenetration force required to insert a blunt cannula 12 through any oneof the septums 22 (e.g., thick, thin, exactly as specified) will beconsistent.

Most preferably, the septum-engaging portion 238 of the swaging tool 232projects downwardly from the housing-engaging portion 240 of the tool232 a distance substantially equal to, or slightly greater than, thewall thickness of the outside end 18 of the housing 16 being swaged. Forexample, if swaging the outside end 18 of a housing 16 having a wallthickness of approximately 0.025 inches (0.635 mm), the septum-engagingportion 238 may project approximately 0.025 inches (0.635 mm) beyond thehousing-engaging portion 240. The housing-engaging portion 240 mostpreferably defines a annular groove (also 240) having rounded surfacesto facilitate bending the housing wall inwardly over the septum 22. Itwill be observed that the foregoing arrangement of the swaging tool 232and pin 234 enables swaging the housing 16 without deforming the septum22 in the longitudinal direction (vertically in the drawings).

Also, preferably, the swaging tool 232 is driven by any suitable means242, such as pneumatic means as illustrated in FIG. 8, that applies alimited, predetermined amount of force to the septum 22 at which pointthe swaging process is complete. Since the septum 22 is incompressibleand constrained from escape by the housing 16, pin 234 andseptum-engaging portion 238 of the swaging tool 232, the force generatedby the swaging tool 232 should be limited to prevent breakage of theapparatus 200 or housing 16.

Indexing means may be provided facilitate stopping each septum-receivingbore 206 of the first turntable 202 and housing-receiving opening 216 ofthe second turntable 204 at the next station of the apparatus 200. Theindexing means may comprise any suitable manually operable means (notshown) including a detent mechanism, such as a plurality of detentcavities (not shown) arranged around the first and second turntables 202and 204 that receive at the proper aligned positions a spring-loadedball (not shown). The manually operable means could comprise amechanical linkage between the two turntables, a drive mechanism, and aratchet mechanism to ensure completion of the slitting, pushing andswaging operations before the turntables are advanced. A lever (notshown) could be included for manual operation of the drive mechanism.

Most preferably, automatic or semi-automatic means are provided foradvancing the turntables 202 and 204; driving the pusher 211, knife 224,pushing tool 230 and swaging tool 232; and indexing the turntables 202and 204 for proper alignment relative to the various stations. Forexample, a preferred semi-automatic means is illustrated in FIG. 8.

Conventional turntable drive mechanisms 244 and 246 are provided toadvance the turntables 202 and 204 from station to station, with thedrive mechanisms 244 and 246 providing an indexing function to stop theturntables 202 and 204 in proper alignment with the stations. The drivemechanisms 244 and 246 are driven by compressed air from a source 248 ofcompressed air, with the drive mechanisms 244 and 246 being providedwith internal pressure regulators (not shown). Rotary indexing tableshaving pneumatic drive mechanisms are commercially available fromAir-Hydraulics, Inc., Jackson, Mich.

A manually operable button 250 is provided for starting the drivemechanisms 244 and 246. The preferred button 250 includes anelectronically-activated reset mechanism to prevent restarting the drivemechanisms 244 and 246 until after a signal has been provided indicatingthat the pushing, slitting and swaging operations have been completed.In the semi-automatic version, an operator would manually load a septum22 into the first turntable 202 at the loading station 210 and a housing16 into the second turntable 204 at the housing-loading station 218before pushing the button 250. Sensing means (not shown) may also beprovided to prevent operation of the button 250 until after a septum 22and housing 16 have been loaded.

Sensors 252 and 254 are provided to sense the position of the turntables202 and 204 to indicate whether they have moved to the proper positions,with the septums 22 and housings 16 advanced to their next stations.Each sensor 252 and 254 provides a signal to an AND gate 256, with theAND gate 256 providing a signal to activate conventional pneumaticvalves 258, 260, 262 and 264 after both turntables 202 and 204 haverotated to their next stations.

The pneumatic valves 258, 260, 262 and 264 permit compressed aircommunication with the pusher mechanism 211, knife mechanism 224,pushing tool 230 and swaging tool 232 to substantially simultaneously(a) push a septum 22 into a septum-receiving bore 206 at the loadingstation 210; (b) cut a slit into a septum 22 at the slitting station212; (c) transfer a slit septum 22 from the unloading station 214 of thefirst turntable 202 into a housing 16 at the septum-loading station 220of the second turntable 204; and (d) swage the outside end 18 of thehousing 16 inwardly over the septum 22 at the swaging station 222.

Each valve 258, 260, 262 and 264 is maintained in compressed aircommunication with the source 248 of compressed air via its respectiveconventional pressure regulator 266, 268, 270 and 272. Most preferably,each pressure regulator 266, 268, 270 and 272 is individually set oradjusted to provide an individually appropriate air pressure to operateeach of the pusher 211, knife 224, pushing tool 230 and swaging tool232. It is also contemplated that the septum-engaging pin 234 could bepneumatically driven in the manner illustrated with respect to theswaging tool 232 and other pneumatically driven tools.

Sensing means 274, 276, 278 and 280 are preferably provided forrespectively sensing the position of the pusher 211, knife 224, pushingtool 230 and swaging tool 232 to determine whether they have (a) movedso as to perform their respective functions (FIG. 11), and (b) returnedto their retracted positions (FIG. 10) to allow the turntables 202 and204 to rotate to their next stations. The sensing means 274, 276, 278and 280 may take any suitable form, including a combination of Halleffect sensors, force indicators and logic circuitry designed todetermine whether the respective tools have performed their functionsand returned. For example, one conventional Hall effect sensor may bepositioned to sense whether a specific tool (e.g., the swaging tool 232)has reached its extreme operational position (e.g., the position whereswaging is completed which is illustrated in FIG. 11), and anotherconventional Hall effect sensor may be positioned to sense whether thattool has returned to its retracted position (FIG. 10).

Each one of the sensing means 274, 276, 278 and 280 provides a signal toan AND gate 282, which in turn provides a signal to the button 250 toreset the button 250. The arrangement is such that the button 250 is notreset (and thus not enabled to trigger rotation of the turntables 202and 204) until after the sensing means 274, 276, 278 and 280 havesignaled that each of the pusher 211, knife 224, pushing tool 230 andswaging tool 232 have performed their functions and returned to theirretracted positions (FIG. 10). As an alternative, the AND gate 282 canprovide its signal directly to the turntable drive mechanisms 244 and246 to automatically advance them without requiring manually operating abutton.

4. Method of Making the Injection Site

The method of making the injection or sampling site 10 is illustrated inFIG. 14. As illustrated in the flow chart, the steps of the method aredivided into two columns 300 and 302. The first column 300 shows the"operational" steps performed on the septum 22 and/or housing 16, whichare preferably performed substantially simultaneously. As used herein,the term "operational steps" merely refer to something being performedon the septums 22 or housings 16 other than rotation of the turntables202 and 204 to advance the septums 22 or housings 16 to their nextstations.

The second column 302 shows the transfer steps 304, 306, 308, 310 and312 during which the septums 22 and/or housings 16 are advanced to thenext stations 210, 212, 214, 218, 220, 222 and 223. The transfer steps304, 306, 308, 310 and 312 most preferably comprise merely rotating theturntables 202 and 204 to advance the septums 22 and housings 16 totheir next stations. All of these transfer steps 304, 306, 308, 310 and312 are performed substantially simultaneously.

The flow chart is also divided into an upper portion designated 202 toindicate that the steps performed in the upper portion of the flow chartare most preferably performed on the first turntable 202, and a lowerportion designated 204 to indicate that the steps performed in the lowerportion of the flow chart are most preferably performed on the secondturntable 204.

The first operational step 314 is to insert an un-slit septum 22 into aseptum-receiving bore 206 at the loading stations 210 of the firstturntable 202. For example, this may be performed by pushing the septum22 into the septum-receiving bore 206 with the pneumatically operatedpusher 211. The un-slit septum 22 is then advanced to the slittingstation 212 in the transfer step 304 by rotating the first turntable202. It will be observed that the sensing means 274 prevents advancingthe septum 22 to the slitting station 212 until after the firstoperational step 314 is completed and the pusher 211 returned to itsretracted position (FIG. 10).

The second operational step 316 is to cut a slit into the septum 22 withthe knife 224 by pushing the knife 224 longitudinally into the septum 22(FIG. 11). The knife 224 may actually be pushed through the septum 22into the knife-receiving opening 226 in the back support 208. After theknife 224 is retracted, the slit septum 22 is advanced to the unloadingstation 214 in the transfer step 306 by rotating the first turntable202. Sensing means 276 prevents advancing the septum 22 to the unloadingstation 214 until after the knife 224 has cut the slit 30 and been movedto its retracted position. Most preferably, the sensing means includesboth Hall effect positional sensors, as described above and a forcesensor or switch to indicate the force applied by the knife 224 to theseptum 22 to determine whether the knife 224 is broken or not to ensurethat a slit 30 is made in each septum 22.

Preferably, at the same time as the first operational step 314 (loadingthe septum 22 into the first turntable 202) is being performed, thethird operational step 318 is performed. The third operational step isto insert a housing 16 into the housing-receiving opening 216 at thehousing-loading station 218 of the second turntable 204. The housing 16may be loaded either manually or automatically, e.g., via a hopper orconveyer means (not shown). After the housing 16 is loaded into thesecond turntable 204 at the housing-loading station 218, the housing 16is advanced to the septum-loading station 220 in the transfer step 308by rotating the second turntable 204. At the septum-loading station 220,the septum-receiving portion 21 of the passageway 20 of the housing 16is aligned with the septum-receiving bore 206 and the passageway 226 ofthe back support 208 that are at their unloading station 214. Mostpreferably, a sensor (not shown) is provided that prevents advancing theturntable 204 if a housing 16 has not been loaded into thehousing-receiving opening 216.

The fourth operational step 320 is to push (with the pushing tool 230)the slit septum 22 out of the septum-receiving opening 206 at theunloading station 214 of the first turntable 202, through the passageway228 of the back support 208, and into the septum-receiving portion 21 ofthe housing 16 held at the septum-loading station 220 of the secondturntable 204. After the slit septum 22 has been loaded into the housing16 at the septum-loading station, the housing 16 and septum 22 areadvanced to the swaging station 22 in the transfer step 310 by rotatingthe second turntable 204. The sensing means 262 prevents advancing theturntable 204 until after the septum 22 has been inserted into thehousing 16 with the pushing tool 230 and the pushing tool 230 has beenmoved to its retracted position.

The fifth operational step 322 can be subdivided into two steps: (a)before swaging the housing 16, inserting a pin 234 into the passageway20 of the housing 16 into engagement with the inside end 24 of theseptum 22, and in particular into the bore 28 of the septum; and then(b) swaging the outside end 18 of the housing 16 held at the swagingstation 222 inwardly over the septum 22.

The step of inserting the pin 234 can be performed simultaneously withthe step of swaging the outside end 18 of the housing 16, or it can beperformed before the swaging process is started. For example, the pin234 could be fixed in the housing-receiving opening 216 of the secondturntable 204 so that it engages the inside end 24 and bore 30 of theseptum 22 when the septum 22 is loaded into the housing 16 at theseptum-loading station 220.

The pin 234 engages the inside end 24 of the septum 22 and fills thebore 28, if any, of the septum 22 to reduce or prevent expansion of theseptum 22 inwardly through the passageway 20 of the housing 16 when theoutside end 18 of the housing 16 is swaged. The swaging tool 232includes a septum-engaging portion 238 which is configured to engage theoutside end 26 of the septum 22 to prevent expansion of the septum 22outwardly. The annular groove 240 constitutes the housing-engagingportion 240 of the swaging tool 232 which is the part of the tool 232that is actually swaging the outside end 18 of the housing 16.

The swaging tool 232 stops trying to swage the housing 16 when the tool232 applies a predetermined amount of force to the septum 22. Forexample, the pressure regulator 272 may be set to regulate this force,or a spring (not shown) may be provide in the swaging tool 232.

After the swaging process is completed, the assembled injection site 10is advanced to the unloading station 223 in transfer step 312 byrotating the second turntable 204. The sensing means 272 preventsadvancing the second turntable 204 until after the swaging process iscompleted and the swaging tool 232 moved to its retracted position. Thesixth operational step 324 is to remove the assembled injection orsampling site 10 from the second turntable 204 at the unloading station223. For example, the site 10 can be ejected from the turntable 204 by ablast of compressed air from the source 248 of compressed air.

It will be observed that various operations may be performed on thedifferent septums 22 and housings 16 at the same time. For example, theoutside end 18 of one housing 16 is swaged at the swaging station 222 atthe same time that a slit 30 is cut into a septum 22 at the slittingstation 212.

On one level, the method includes two general steps 300 and 302: (a)performing various operations on the septums and housings 16 (e.g.,operational steps 314, 316, 318, 320, 322 and 324); and (b) transferringthe septums 22 and housings 16 to their next stations (e.g., transfersteps 304, 306, 308, 310 and 312). These two general steps 300 and 302are performed in alternating fashion.

As various changes could be made in the above constructions and methodswithout departing from the scope of the invention, it is intended thatall matter contained in the above description or shown in theaccompanying drawing be interpreted as illustrative and not in alimiting sense.

We claim:
 1. A method of fabricating an injection or sampling siteadapted to receive a blunt cannula, the method comprising the stepsof:providing a housing having an outside end and a passageway extendinginwardly from the outside end, the passageway opening through theoutside end and defining a longitudinal direction; providing anelastomeric septum having an outside end corresponding to the outsideend of the housing and an inside end opposite its outside end; insertingthe elastomeric septum into the passageway of the housing; inserting apin into the passageway of the housing to engage the inside end of theseptum to reduce or prevent expansion of the septum inwardly through thepassageway when the outer end of the housing is swaged; and during orafter the step of inserting the pin, swaging the outside end of thehousing inwardly over the septum with a swaging tool.
 2. A methodaccording to claim 1 further comprising:during the step of swaging theoutside end of the housing inwardly over the septum with a swaging tool,directly engaging the septum with a septum-engaging portion of theswaging tool; and stopping the swaging process when the swaging toolapplies a predetermined amount of force to the septum.
 3. A methodaccording to claim 2 wherein the septum has a bore extending part-waythrough the septum from the inside end of the septum; the step ofinserting a pin into the passageway of the housing including insertingthe pin into the bore of the septum.
 4. A method according to claim 3wherein the swaging tool has a septum-engaging portion and ahousing-swaging portion, the step of stopping the swaging processfurther comprising engaging the septum with the septum-engaging portionof the swaging tool before stopping the swaging process.
 5. A methodaccording to claim 2 wherein the step of providing an elastomeric septumincludes the step of cutting a slit into the septum before the septum isinserted into the passageway of the housing.
 6. A method according toclaim 5 wherein the step of cutting a slit into the septumcomprises:providing an apparatus for slitting the septum comprising ablock having a septum-receiving bore, a back support for supporting oneend of the septum, and a knife; inserting the septum into theseptum-receiving bore against the back support, with theseptum-receiving bore laterally constraining the septum to preventlateral deformation of the septum; cutting the slit into the septum withthe knife axially aligned with the septum-receiving bore; and removingthe septum from the septum-receiving bore.
 7. A method according toclaim 6 wherein the back support has a passageway sized to allow theseptum to be pushed through the passageway of the back support, theblock being movable relative to the back support between a slittingstation, in which the passageway of the back support is not adjacent theseptum-receiving bore of the block, and an unloading station, in whichthe septum-receiving bore of the block is aligned with the passageway ofthe back support, the apparatus further comprising a pushing tool forpushing the septum out of the septum-receiving bore and through thepassageway of the back support;the step of removing the septum from theseptum-receiving bore comprising: moving the block relative to the backsupport to the unloading station; and pushing the septum out of theseptum-receiving bore and through the passageway of the back supportwith the pushing tool.
 8. A method according to claim 7 wherein the stepof inserting the septum into the septum-receiving bore against the backsupport includes inserting the septum into the septum-receiving boresuch that the inside end of the septum engages the back support;the stepof inserting the elastomeric septum into the passageway of the housingcomprising: aligning the passageway of the housing with theseptum-receiving bore of the block and passageway of the back support atthe unloading station; and after the step of pushing the septum out ofthe septum-receiving bore, continuing to push the septum with thepushing tool into the passageway of the housing.
 9. A method accordingto claim 6 wherein the back support has a knife-receiving opening, thestep of cutting the slit into the septum comprising pushing the knifeinto the septum toward the knife-receiving opening.
 10. A methodaccording to claim 2 wherein the swaging tool has a septum-engagingportion and a housing-swaging portion, the step of stopping the swagingprocess further comprising engaging the septum with the septum-engagingportion of the swaging tool before stopping the swaging process.
 11. Amethod according to claim 10 wherein the septum-engaging portion andhousing-swaging portion of the swaging tool are configured such that theseptum-engaging portion of the swaging tool applies the predeterminedforce to the septum without the swaged outside end of the housingapplying longitudinal compression to the septum; the step of stoppingthe swaging process comprising:stopping the swaging process before theswaged outside end of the housing applies longitudinal compression tothe septum.
 12. A method according to claim 2 wherein the housing has aninner ledge defining the inner end of a septum-receiving portion of thepassageway; the step of inserting the septum into the passagewaycomprising inserting the septum into the passageway such that the insideend of the septum engages the inner ledge.
 13. A method according toclaim 12 wherein the septum has a bore extending part-way through theseptum from the inside end of the septum; the step of inserting a pininto the passageway of the housing including inserting the pin into thebore of the septum.
 14. A method according to claim 13 wherein theswaging tool has a septum-engaging portion and a housing-swagingportion, the step of stopping the swaging process further comprisingengaging the septum with the septum-engaging portion of the swaging toolbefore stopping the swaging process.
 15. A method according to claim 12wherein the swaging tool has a septum-engaging portion and ahousing-swaging portion, the step of stopping the swaging processfurther comprising engaging the septum with the septum-engaging portionof the swaging tool before stopping the swaging process.
 16. A methodaccording to claim 15 wherein the septum-engaging portion andhousing-swaging portion of the swaging tool are configured such that theseptum-engaging portion of the swaging tool applies the predeterminedforce to the septum without the swaged outside end of the housingapplying longitudinal compression to the septum; the step of stoppingthe swaging process comprising:stopping the swaging process before theswaged outside end of the housing applies longitudinal compression tothe septum, the swaged outside end of the housing defining an outerledge defining the outer end of the septum-receiving portion of thepassageway.
 17. A method according to claim 1 wherein the septum has abore extending part-way through the septum from the inside end of theseptum; the step of inserting a pin into the passageway of the housingincluding inserting the pin into the bore of the septum.
 18. A methodaccording to claim 1 wherein the step of providing an elastomeric septumincludes the step of cutting a slit into the septum before the septum isinserted into the passageway of the housing.
 19. A method according toclaim 18 wherein the step of cutting a slit into the septumcomprises:providing an apparatus for slitting the septum comprising ablock having a septum-receiving bore, a back support for supporting oneend of the septum, and a knife; inserting the septum into theseptum-receiving bore against the back support, with theseptum-receiving bore laterally constraining the septum to preventlateral deformation of the septum; cutting the slit into the septum withthe knife axially aligned with the septum-receiving bore; and removingthe septum from the septum-receiving bore.
 20. A method according toclaim 19 wherein the back support has a passageway sized to allow theseptum to be pushed through the passageway of the back support, theblock being movable relative to the back support between a slittingstation, in which the passageway of the back support is not adjacent theseptum-receiving bore of the block, and an unloading station, in whichthe septum-receiving bore of the block is aligned with the passageway ofthe back support, the apparatus further comprising a pushing tool forpushing the septum out of the septum-receiving bore and through thepassageway of the back support;the step of removing the septum from theseptum-receiving bore comprising: moving the block relative to the backsupport to the unloading station; and pushing the septum out of theseptum-receiving bore and through the passageway of the back supportwith the pushing tool.
 21. A method according to claim 20 wherein thestep of inserting the septum into the septum-receiving bore against theback support includes inserting the septum into the septum-receivingbore such that the inside end of the septum engages the back support;thestep of inserting the elastomeric septum into the passageway of thehousing comprising: aligning the passageway of the housing with theseptum-receiving bore of the block and passageway of the back support atthe unloading station; and after the step of pushing the septum out ofthe septum-receiving bore, continuing to push the septum with thepushing tool into the passageway of the housing.
 22. A method accordingto claim 19 wherein the back support has a knife-receiving opening, thestep of cutting the slit into the septum comprising pushing the knifeinto the septum toward the knife-receiving opening.
 23. A methodaccording to claim 1 wherein the housing has an inner ledge defining theinner end of a septum-receiving portion of the passageway; the step ofinserting the septum into the passageway comprising inserting the septuminto the passageway such that the inside end of the septum engages theinner ledge.
 24. A method according to claim 23 wherein the septum has abore extending part-way through the septum from the inside end of theseptum; the step of inserting a pin into the passageway of the housingincluding inserting the pin into the bore of the septum.
 25. A method offabricating an injection or sampling site adapted to receive a bluntcannula, the method comprising the steps of:providing a housing havingan outside end and a passageway extending inwardly from the outside end,the passageway opening through the outside end and defining alongitudinal direction; inserting an elastomeric septum into thepassageway of the housing; swaging the outside end of the housinginwardly over the septum with a swaging tool, the swaging tool having aseptum-engaging portion configured for directly engaging the septumbefore the swaged outside end of the housing applies longitudinalcompression to the septum; during the step of swaging the outside end ofthe housing inwardly over the septum with a swaging tool, directlyengaging the septum with the septum-engaging portion of the swagingtool; and during he step of directly engaging the septum with theseptum-engaging portion of the swain tool and before the swaged outsideend of the housing applies longitudinal compression to the septum,stopping the swaging process when the swaging tool applies apredetermined amount of force to the septum at the location where theseptum-engaging portion of the swaging tool is engaging the septum. 26.A method according to claim 25 further comprising the step of cutting aslit into the septum before the septum is inserted into the passagewayof the housing.
 27. A method according to claim 25 wherein the housinghas an inner ledge defining the inner end of a septum-receiving portionof the passageway; the step of inserting the septum into the passagewaycomprising inserting the septum into the passageway such that the insideend of the septum engages the inner ledge.
 28. A method of fabricatingan injection or sampling site adapted to receive a blunt cannula, themethod comprising the steps of:providing a housing having an outside endand a passageway extending inwardly from the outside end, the passagewayopening through the outside end and defining a longitudinal direction;inserting an elastomeric septum into the passageway of the housing, theseptum having an outside end corresponding to the outside end of thehousing, and an inside end opposite the outside end of the septum;swaging the outside end of the housing inwardly over the septum with aswaging tool, the swaging tool having a septum-engaging portionconfigured for directly engaging the septum before the swaged outsideend of the housing applies longitudinal compression to the septum;before or during the step of swaging the outer end of the housing,inserting a pin into the passageway of the housing to engage the insideend of the septum to reduce or prevent expansion of the septum inwardlythrough the passageway when the outer end of the housing is swaged; andstopping the swaging process when the swaging tool applies apredetermined amount of force to the septum at the location where theseptum-engaging portion of the swain tool is engaging the septum.
 29. Amethod according to claim 28 wherein the septum has a bore extendingpart-way through the septum from the inside end of the septum; the stepof inserting a pin into the passageway of the housing includinginserting the pin into the bore of the septum.
 30. A method offabricating an injection or sampling site adapted to receive a bluntcannula, the method comprising the steps of:providing a housing havingan outside end and a passageway extending inwardly from the outside end,the passageway opening through the outside end and defining alongitudinal direction; inserting an elastomeric septum into thepassageway of the housing; swaging the outside engage of the housinginwardly over the septum with a swaging tool, the swaging tool having aseptum-engaging portion configured for directly engaging the septumbefore the swaged outside end of the housing applies longitudinalcompression to the septum; and stopping the swaging process when theswaging tool applies a predetermined amount of force to the septum atthe location where the septum-engaging portion of the swaging tool isengaging the septum; the method further comprising cutting a slit intothe septum before the septum is inserted into the passageway of thehousing, the step of cutting a slit into the septum comprises: providingan apparatus for slitting the septum comprising a block having aseptum-receiving bore, a back support for supporting one end of theseptum, and a knife; inserting the septum into the septum-receiving boreagainst the back support; cutting the slit into the septum; and removingthe septum from the septum-receiving bore.
 31. A method according toclaim 20 wherein the back support has a passageway sized to allow theseptum to be pushed through the passageway of the back support, theblock being movable relative to the back support between a slittingstation, in which the passageway of the back support is not adjacent theseptum-receiving bore of the block, and an unloading station, in whichthe septum-receiving bore of the block is aligned with the passageway ofthe back support, the apparatus further comprising a pushing tool forpushing the septum out of the septum-receiving bore and through thepassageway of the back support;the step of removing the septum from theseptum-receiving bore comprising: moving the block to the unloadingstation; and pushing the septum out of the septum-receiving bore andthrough the passageway of the back support with the pushing tool.
 32. Amethod according to claim 31 wherein the step of inserting the septuminto the septum-receiving bore against the back support includesinserting the septum into the septum-receiving bore such that the insideend of the septum engages the back support;the step of inserting theelastomeric septum into the passageway of the housing comprising:aligning the passageway of the housing with the septum-receiving bore ofthe block and passageway of the back support, at the unloading station;and after the step of pushing the septum out of the septum-receivingbore, continuing to push the septum with the pushing tool into thepassageway of the housing.
 33. A method according to claim 30 whereinthe back support has a knife-receiving opening, the step of cutting theslit into the septum comprising pushing the knife into the septum towardthe knife-receiving opening.
 34. A method of fabricating an injection orsampling site adapted to receive a blunt cannula, the method comprisingthe steps of:providing a housing having an outside end and a passagewayextending inwardly from the outside end, the passageway opening throughthe outside end and defining a longitudinal direction; inserting anelastomeric septum into the passageway of the housing; swaging theoutside end of the housing inwardly over the septum with a swaging tool,the swaging tool having a septum-engaging portion configured fordirectly engaging the septum before the swaged outside end of thehousing applies longitudinal compression to the septum; and stopping theswaging process when the swaging tool applies a predetermined amount offorce to the septum at the location where the septum-engaging portion ofthe swaging tool is engaging the septum; the septum-engaging portion andhousing-swaging portion of the swaging tool being configured such thatthe septum-engaging portion of the swaging tool applies thepredetermined force to the septum without the swaged outside end of thehousing applying longitudinal compression to the septum; the step ofstopping the swaging process comprising: stopping the swaging processbefore the swaged outside end of the housing applies longitudinalcompression to the septum.
 35. A method of fabricating an injection orsampling site adapted to receive a blunt cannula, the method comprisingthe steps of:providing a housing having an outside end and a passagewayextending inwardly from the outside end, the passageway opening throughthe outside end and defining a longitudinal direction, the housinghaving an inner ledge defining the inner end of a septum-receivingportion of the passageway; inserting an elastomeric septum into thepassageway of the housing such that the inside end of the septum engagesthe inner ledge; swaging the outside end of the housing inwardly overthe septum with a swaging tool, the swaging tool having aseptum-engaging portion configured for directly engaging the septumbefore the swaged outside end of the housing applies longitudinalcompression to the septum; and stopping the swaging process when theswaging tool applies a predetermined amount of force to the septum atthe location where the septum-engaging portion of the swaging tool isengaging the septum; the septum-engaging portion and housing-swagingportion of the swaging tool being configured such that theseptum-engaging portion of the swaging tool applies the predeterminedforce to the septum without the swaged outside end of the housingapplying longitudinal compression to the septum; the step of stoppingthe swaging process comprising: stopping the swaging process before theswaged outside end of the housing applies longitudinal compression tothe septum, the swaged outside end of the housing defining an outerledge defining the outer end of the septum-receiving portion of thepassageway.
 36. A method comprising:providing an elastomeric septum;providing an apparatus for slitting the septum comprising a block havinga septum-receiving bore, a back support for supporting one end of theseptum, and a knife; inserting the septum into the septum-receiving boreagainst the back support, and constraining the septum in theseptum-receiving bore against lateral deformation; cutting the slit intothe septum with the knife axially aligned with the septum-receivingbore; after cutting the slit into the septum, removing the septum fromthe septum-receiving bore; and during or after removal of the septumfrom the septum-receiving bore, inserting the septum into a housing ofan injection or sampling site.
 37. A method according to claim 36wherein the back support has a knife-receiving opening, the step ofcutting the slit into the septum comprising pushing the knife into theseptum toward the knife-receiving opening.
 38. A method according toclaim 36 wherein the back support has a passageway sized to allow theseptum to be pushed through the passageway of the back support, theblock being movable relative to the back support between a slittingstation, in which the passageway of the back support is not adjacent theseptum-receiving bore of the block, and an unloading station, in whichthe septum-receiving bore of the block is aligned with the passageway ofthe back support, the apparatus further comprising a pushing tool forpushing the septum out of the septum-receiving bore and through thepassageway of the back support;the step of removing the septum from theseptum-receiving bore comprising: moving the block to the unloadingstation; and pushing the septum out of the septum-receiving bore andthrough the passageway of the back support with the pushing tool.
 39. Amethod according to claim 38 further comprising the step of insertingthe septum into a passageway of a housing after the steps of slittingthe septum and removing the septum from the septum-receiving bore.
 40. Amethod according to claim 39 wherein the septum has an inside end and anoutside end opposite the inside end; the step of inserting the septuminto the septum-receiving bore against the back support includinginserting the septum into the septum-receiving bore such that the insideend of the septum engages the back support;the step of inserting theelastomeric septum into the passageway of the housing comprising:aligning the passageway of the housing with the septum-receiving bore ofthe block and passageway of the back support; and after the step ofpushing the septum out of the septum-receiving bore, continuing to pushthe septum with the pushing tool into the passageway of the housing. 41.A method according to claim 40 wherein the block comprises a turntablehaving a plurality of septum-receiving bores mounted for rotationrelative to the back support to move the septum-receiving bores relativeto back support between the slitting and unloading stations;the step ofmoving the block to the unloading station comprising rotating theturntable to move one of the septum-receiving bores into alignment withthe passageway of the back support.
 42. A method according to claim 41wherein the turntable constitutes a first turntable, a second rotatableturntable being provided having a plurality of housing-receivingopenings for receiving the housing of the injection or sampling site,the second turntable being positioned such that one housing-receivingopening is aligned with the passageway of the back support and beingrotatable to bring a next housing-receiving opening into alignment withthe passageway of the back support;the step of aligning the passagewayof the housing with the septum-receiving bore of the block andpassageway of the back support comprising rotating the second turntableto bring the next housing-receiving opening into alignment with thepassageway of the back support as one of the septum-receiving bores ismoved into alignment with the passageway of the back support.
 43. Amethod according to claim 42 wherein the second turntable is rotatableto move the housing-receiving openings between a septum-loading station,in which a housing-receiving opening is aligned with the passageway ofthe back support, and a swaging station, in which the housing-receivingopening is aligned with a swaging tool for swaging an outside end of ahousing located in that housing-receiving opening inwardly over a septumthat was inserted into the passageway of the housing in theseptum-loading station, the housing having an outside end and apassageway extending inwardly from the outside end, the passageway ofthe housing opening through the outside end and defining a longitudinaldirection;the method further comprising: after inserting a septum into ahousing located in a housing-receiving opening at the septum-loadingstation, rotating the second turntable to move the housing-receivingopening from the septum-loading station to the swaging station; andswaging, with the swaging tool, the outside end of the housing locatedin the housing-receiving opening that is at the swaging station inwardlyover the septum inserted into the passageway of that housing.
 44. Amethod according to claims 43 wherein the steps of cutting the slit intothe septum, pushing the septum out of the septum-receiving bore andthrough the passageway of the back support, continuing to push theseptum with the pushing tool into the passageway of the housing, andswaging the outside end of the housing inwardly over the septum areperformed substantially simultaneously on different septums and housingspositioned at the different stations.
 45. A method according to claim 43further comprising the steps of:before or during the step of swaging theoutside end of the housing inwardly over the septum, inserting a pininto the passageway of the housing to engage the inside end of theseptum to reduce or prevent expansion of the septum inwardly through thepassageway when the outer end of the housing is swaged; during the stepof swaging the outside end of the housing inwardly over the septum withthe swaging tool, directly engaging the septum with a septum-engagingportion of the swaging tool; and stopping the swaging process when theswaging tool applies a predetermined amount of force to the septum. 46.A method according to claim 45 wherein the septum has a bore extendingpart-way through the septum from the inside end of the septum; the stepof inserting a pin into the passageway of the housing includinginserting the pin into the bore of the septum.
 47. A method according toclaim 46 wherein the swaging tool has a septum-engaging portion and ahousing-swaging portion, the step of stopping the swaging processfurther comprising engaging the septum with the septum-engaging portionof the swaging tool before stopping the swaging process.
 48. A methodaccording to claim 45 wherein the swaging tool has a septum-engagingportion and a housing-swaging portion, the step of stopping the swagingprocess further comprising engaging the septum with the septum-engagingportion of the swaging tool before stopping the swaging process.
 49. Amethod according to claim 48 wherein the septum-engaging portion andhousing-swaging portion of the swaging tool are configured such that theseptum-engaging portion of the swaging tool applies the predeterminedforce to the septum without the swaged outside end of the housingapplying longitudinal compression to the septum; the step of stoppingthe swaging process comprising:stopping the swaging process before theswaged outside end of the housing applies longitudinal compression tothe septum.
 50. A method according to claim 45 wherein the housing hasan inner ledge defining the inner end of a septum-receiving portion ofthe passageway; the step of inserting the septum into the passageway ofthe housing comprising inserting the septum into the passageway suchthat the inside end of the septum engages the inner ledge.
 51. A methodaccording to claim 50 wherein the septum has a bore extending part-waythrough the septum from the inside end of the septum; the step ofinserting a pin into the passageway of the housing including insertingthe pin into the bore of the septum.
 52. A method according to claim 51wherein the swaging tool has a septum-engaging portion and ahousing-swaging portion, the step of stopping the swaging processfurther comprising engaging the septum with the septum-engaging portionof the swaging tool before stopping the swaging process.
 53. A methodaccording to claim 50 wherein the swaging tool has a septum-engagingportion and a housing-swaging portion, the step of stopping the swagingprocess further comprising engaging the septum with the septum-engagingportion of the swaging tool before stopping the swaging process.
 54. Amethod according to claim 53 wherein the septum-engaging portion andhousing-swaging portion of the swaging tool are configured such that theseptum-engaging portion of the swaging tool applies the predeterminedforce to the septum without the swaged outside end of the housingapplying longitudinal compression to the septum; the step of stoppingthe swaging process comprising:stopping the swaging process before theswaged outside end of the housing applies longitudinal compression tothe septum, the swaged outside end of the housing defining an outerledge defining the outer end of the septum-receiving portion of thepassageway.